Tags: amyotrophic lateral sclerosis | als | biogen | qalsody | fda | approval | accelerated

FDA Gives Accelerated Approval to Biogen's ALS Drug

'ALS' in block letters surrounded by pills, vial, syringe
(Dreamstime)

Tuesday, 25 April 2023 01:50 PM EDT

The U.S. Food and Drug Administration has approved Biogen Inc's drug for treating an inherited form of amyotrophic lateral sclerosis (ALS), the health regulator said on Tuesday.

The drug, branded as Qalsody, got a green light under the agency's accelerated approval pathway that allows for speedy access to treatments which target serious and life-threatening conditions, making it the first available therapy for genetic ALS.

The drug's approval is based on data that showed it reduced levels of neurofilament protein, which is an indicator of nerve cell degeneration that is believed to be tied with progression of the symptoms of the disease.

The company will be required to provide more data on the drug's effectiveness for it to remain on the market and for the FDA to grant full traditional approval.

A panel of FDA experts in March voted in favor of an accelerated approval, but the same panel voted that data from trials of the drug did not support full approval. 

© 2025 Thomson/Reuters. All rights reserved.


Health-News
The U.S. Food and Drug Administration has approved Biogen Inc's drug for treating an inherited form of amyotrophic lateral sclerosis (ALS), the health regulator said on Tuesday. The drug, branded as Qalsody, got a green light under the agency's accelerated approval pathway...
amyotrophic lateral sclerosis, als, biogen, qalsody, fda, approval, accelerated
161
2023-50-25
Tuesday, 25 April 2023 01:50 PM
Newsmax Media, Inc.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 
Find Your Condition
Get Newsmax Text Alerts
TOP

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved
NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved